DAY 1 - Tuesday 28th February 2012

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8am	Registration and refreshments
9am	Chairman’s opening remarks Dr Alain Pralong Alain Pralong obtained his doctorate in molecular and cellular biology at the University of Berne in 2000. His research into apoptosis was conducted jointly between the University and Novartis, where all laboratory-based investigations were carried ... more.. › Dr Alain Pralong, VP process industrialization and new product introduction, GSK
	OPTIMISATION OF CELL CULTURE BIOLOGIC PRODUCTION
9.10am	Applying QbD concept for the manufacture of biotech drug substance: is the design space dependent or independent of scale? Dr Hervé Broly Starting with an Engineering degree coupled with a doctorate in Physiology, Hervé Broly developed the manufacture of monoclonal antibodies for diagnostic reagent and therapeutical use at the Regional Blood Transfusion Center of Lille (France) from... more.. Merck Serono has developed the concept of Global Multi-step Design Space The Design Space is almost developed on the basis of DoE experiments done at small-scale Small-scale models were qualified by comparison with large-scale data obtained at central points Are the limits of the Design Space still valid at manufacturing scale? › Dr Hervé Broly, Vice President Biotech Process Sciences, Merck Serono
9.40am	Combining elements of process intensification, single use systems and advanced monitoring and control technology for the next generation cell culture processes Dr Thomas Ryll Thomas completed his PhD in Biochemistry and Biotechnology in 1992 at the Technical University of Braunschweig, Germany. After a year PostDoc he joined Genentech in 1993. At Genentech he was involved in the development of the first generation of... more.. Can disposable bioreactors support intensified culture formats delivering high titers? Exploring how the application of Raman Spectroscopy to culture monitoring and control can help improve process understanding and aid future developments What will the next generation culture process likely look like? › Dr Thomas Ryll, Senior Director, Cell Culture Development, Biogen Idec
10.20am	How to lifecycle manage the entire manufacturing process Dr Alain Bernard Dr. Alain Bernard is currently Vice-President, Biopharmaceutical Process Sciences at UCB, overseeing process developments for new chemical and new biological entities as well as for life-cycle management of marketed products. He joined UCB in... more.. Considering the whole process from the outset and the impact this can have on reducing production time scales Exploring the potential of quality by design for improving operational efficiency Highlighting the impact these changes can have through case studies › Dr Alain Bernard, VP Biopharma Process Sciences (BPS), UCB SA
10.50am	Speed Networking
11.20am	Morning refreshments
11.50am	Debottlenecking antibody development pipelines to increase throughput of new product opportunities Dr Kevin Bailey Kevin Bailey has 25 years of experience in the biopharmaceutical industry, 20 of those at Regeneron Pharmaceuticals, Inc.,where he is Vice President of Preclinical Manufacturing and Process Development. He is responsible for leading all development ... more.. Highlighting that growth in the biopharmaceutical space is driven by product innovation and high-throughput strategies to identify new targets, and quickly get to POC in patients Exploring these high throughput development strategies which are needed to get new therapeutic opportunities to patients Is true process optimization best carried out "off the critical path"? › Dr Kevin Bailey, Vice President Preclinical Manufacturing and Process Development, Regeneron
12.20pm	Continuous Cell Culture Process Optimization using Global Metabolomic Profiling Dr Thomas Jonsson Dr. Jönsson received training in Chemistry, Biochemistry and Molecular Biology at Lund University and Wake Forest University School of Medicine where he gained expertise in the oxidative stress field. Dr. Jönsson joined Metabolon in 2009 and is the... more.. Comprehensive and integrated biochemical approach to media formulation and process development Case studies illustrating applications for optimization of: product quality, process productivity and variability Using metabolomics to develop the next generation of biologic production platforms › Dr Thomas Jonsson, Associate Director of Project Management, Metabolon
12.50pm	Case study: producing high titres of a next generation therapeutic antibody Dr Ingo Gorr Ingo Gorr received his Biology degree from the University of Wurzburg in Germany, followed by a PhD in the Molecular Cell Biology department at the Max-Planck-Institute of Biochemistry in Martinsried/Germany. His research focused on the discovery of ... more.. Exploring the strategies employed to engineer a bispecific antibody format Understanding how a stable manufacturing cell line was generated with standard cell culture techniques Highlighting the performance of the new molecule format in large scale production of API in pharmaceutical quality › Dr Ingo Gorr, Senior Scientist Cell Culture Research, Roche Pharmaceuticals
1.20pm	Networking lunch
	EXPLORING THE POTENTIAL OF CELL LINE ENGINEERING
2.20pm	Enabling cost-effective product quality focus in early biopharmaceutical development Can we achieve high titer production cell lines, desired product quality, and speed to clinic simultaneously? Emerging and existing cell line and cell culture technologies for improved product quality before the proof of concept clinical stage Understanding overall time and cost benefits of a product quality focus from the beginning of process development › Dr Florian Wurm, Professor of Biochemistry, University of Lausanne
2.50pm	Automatic High Content Screening for Life Sciences Dr Boris Zarda Diploma in Biology, TU Munich in 1991. Main topic Microbiology PhD in natural sciences, TU Munich in 1995. Identification of Microorganisms with labeled rRNA targeted oligonucleotides. Development of several different detection systems. ETH Zurich... more.. Evaluating the flexibility which results from combining high-performance acquisition systems tailored to your needs, with the new ingenious LAS AF MATRIX M3 software platform Why optimise all configurations for automated imaging in multi dimensions at high speed and offer unique interfaces?   How customized imaging systems that enable you to tailor a solution perfectly fitting your needs › Dr Boris Zarda, Field Support Manager Europe, Life Sciences Science Division - Research, Leica Microsystems GmbH
3.20pm	Could automation be the answer to optimal cell line identification? Dr Anne Tolstrup Dr. Anne Tolstrup joined Boehringer-Ingelheim Biopharma in 2011 where she holds the position as Director for Cell Culture II in the Process Science department. Here, her group is dealing with all aspects of mammalian cell line development for... more.. What are the limiting factors of existing early predictive tools? Identification of rare, high-producing cell lines using automated platforms – could this allow better efficiency in identifying the right clones? Considering the downstream processes from the beginning to improve overall process efficiency › Dr Anne Tolstrup, Head of Cell Culture II, Process Sciences, Biopharma, Boehringer Ingelheim GmbH & Co. KG
3.50pm	Afternoon refreshments
4.20pm	Update on CAP cells - immortalized human amniocytes as a versatile expression platform for complex proteins, vaccines and viruses Dr Harmut Tintrup Hartmut Tintrup received his Ph.D. in 1998 from Frankfurt University, Germany. After finishing his Ph.D. thesis at the Max-Planck-Institute for Brain Research in Frankfurt he worked first as a Research Scientist at Artemis Pharmaceuticals... more.. How have CAP cells developed in the last 12 months and is there still more to come? Understanding the significant benefits to biologic activity and therapeutic efficacy that results from utilising authentic posttranslational modifications Exploring the implications of recent expression data that indicated that CAP cells are also an efficient tool for the production of various human viruses › Dr Harmut Tintrup, Director Marketing & Business Development, CEVEC Pharmaceuticals
4.50pm	Panel discussion: evaluating the opportunities to develop cell culture bio-production Moderator: Dr Alain Pralong Alain Pralong obtained his doctorate in molecular and cellular biology at the University of Berne in 2000. His research into apoptosis was conducted jointly between the University and Novartis, where all laboratory-based investigations were carried ... more.. Dr Anne Tolstrup Dr. Anne Tolstrup joined Boehringer-Ingelheim Biopharma in 2011 where she holds the position as Director for Cell Culture II in the Process Science department. Here, her group is dealing with all aspects of mammalian cell line development for... more.. Dr Christine DeMaria Christine DeMaria is a Senior Scientist in the Cell Line and Cell Culture Process Development group at Genzyme. Dr. DeMaria received her B.S. in Biology from Tufts University and her Ph.D. in Microbiology and Immunology from Wake Forest University... more.. Dr Kevin Bailey Kevin Bailey has 25 years of experience in the biopharmaceutical industry, 20 of those at Regeneron Pharmaceuticals, Inc.,where he is Vice President of Preclinical Manufacturing and Process Development. He is responsible for leading all development ... more.. Dr Hervé Broly Starting with an Engineering degree coupled with a doctorate in Physiology, Hervé Broly developed the manufacture of monoclonal antibodies for diagnostic reagent and therapeutical use at the Regional Blood Transfusion Center of Lille (France) from... more.. Dr Thomas Ryll Thomas completed his PhD in Biochemistry and Biotechnology in 1992 at the Technical University of Braunschweig, Germany. After a year PostDoc he joined Genentech in 1993. At Genentech he was involved in the development of the first generation of... more.. Given the need to produce biologics faster and cheaper, what strategies are the industry looking to in the future to achieve this? Can understanding the benefits and limitations of different cell culture procedures aid in achieving the desired product in the shortest time with maximum yields? Evaluating current technologies and methodologies which could deliver an optimized end-to-end production systems › Dr Alain Pralong, VP process industrialization and new product introduction, GSK › Dr Anne Tolstrup, Head of Cell Culture II, Process Sciences, Biopharma, Boehringer Ingelheim GmbH & Co. KG › Dr Christine DeMaria, Senior Scientist, Therapeutic Protein Expression, Genzyme Corporation › Dr Kevin Bailey, Vice President Preclinical Manufacturing and Process Development, Regeneron › Dr Hervé Broly, Vice President Biotech Process Sciences, Merck Serono › Dr Thomas Ryll, Senior Director, Cell Culture Development, Biogen Idec
5.35pm	Close of Day 1 followed by Networking Drinks